Pan-tumor types with HER2 mutation or low expression that fail standard treatment
Conditions
Interventions
Queue F: Other tumor types:None
Queue A: Biliary tract cancer group:None
Queue E: Gynecological tumors:None
Queue C: Urothelial carcinoma:None
Queue D: Head and neck tumors:None
Queue B: Digestive tract tumors:None
Sponsors
The first affiliated hospital of anhui medical university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form and voluntarily join this study; 2. Histologically/cytologically confirmed advanced/metastatic solid tumors; 3. Age >= 18 years old; 4. Definitive test results confirm the presence of HER2 alterations, including HER2 mutations, HER2 amplifications, or HER2 positive expression (IHC 3+ or IHC 2+/ISH+) or HER2 low expression (IHC 2+/ISH- or IHC 1+); 5. Refractory to at least one treatment method or unable to accept/tolerate standard therapy; 6. ECOG performance status score of 0-2; 7. Expected survival duration >= 3 months; 8. Have at least one measurable lesion according to RECIST 1.1; 9. Laboratory test values within 14 days prior to enrollment meet the following requirements: a. Blood routine examination: (excluding hemoglobin, no blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF], and no medication correction within 2 weeks before screening): absolute neutrophil count >=1.5×10^9/L; platelet count >=75×10^9/L; hemoglobin >=90 g/L; b. Biochemical examination: serum albumin =30g/L; total serum bilirubin 50 ml/min; c. Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%; 10. The researchers determined that the patient could receive either trastuzumab alone or in combination therapy.
Exclusion criteria
Exclusion criteria: 1. Patients who have simultaneously received treatment with other similar drugs; 2. Those who are pregnant or breastfeeding, or unwilling/unable to adopt effective contraception; 3. Active pneumonia/interstitial lung disease (ILD) requiring systemic treatment, or previous severe drug-related pneumonia that has not yet stabilized; 4. Known history of severe allergic reactions to SHR-A1811 or its excipients; 5. Uncontrolled severe infections (such as sepsis/requiring intravenous anti-infection and being unstable, etc.); 6.Other situations where the researchers believe the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Safety;Overall Survival;Progress Free Survival; | — |
Countries
China
Contacts
Public ContactGu Kangsheng
The first affiliated hospital of anhui medical university
Outcome results
None listed